Etude prospective, contrôlée, randomisée du traitement de l’occlusion sévère de la veine centrale de la rétine à sa phase précoce par injection intra-vitréenne de Bevacizumab - OVCR

• Conditions: retinal vein occlusion

• Registration Number: EUCTR2009-017735-18-FR
• Lead Sponsor: CHRU Montpellier - Direction de la Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age included between 18 years and 85 years
OVCR recent diagnosis (< 3 months)
initial Visual Acuteness < 20/40 th (in scale ETDRS)
Oedema maculaire significant upper to 250 microns on OCT
Participation of the subject in the study noted in the medical file
Collection of the subject consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Leukaemia, Myelome, Thrombophlebite, Disease of Vaquez, Disease of Osler, Disease of Behçet
Amblyopic eye
Diabetic maculopathie, Retinopathie diabetic
Occlusion of the central artery of the associated retina (OACR) or Occlusion of the cilio-retinal artery
Occlusion of branch of the central vein of the retina ( OBVCR)
Other treatment of the OVCR undertaken before the inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficiency of premature covercare of the OVCR including a series of 3 intravitreal injections of Bevacizumab;Secondary Objective: Evaluation of the quality of visual function by means of a standardized questionnaire<br>Evaluation of the oedema maculaire in OCT (Tomography in Optical Coherence)<br>Evaluation and comparison of the tolerance of the treatment by Bevacizumab<br>Research of complications of the OVCR;Primary end point(s): gain of visual acuteness measured in 6 months after the inclusion blind according to the international standards ETDRS and secondarily converted in acuteness logMAR.